Fecal MicrobiotaTransplant for the Treatment of Parkinson's Disease

NCT ID: NCT06647277

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-07-31

Study Completion Date

2027-12-31

Brief Summary

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FMT may significantly improve quality of life and Parkinson Disease (PD) symptom severity measurements. We hypothesize that gut microbial dysbiosis is a major contributing factor in Parkinson's disease.

Detailed Description

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This is an open-label clinical trial to evaluate the Safety of fecal microbiota transplant following a 10 day treatment with Vancomycin in adult subjects with Parkinson's disease. Subjects in the study are required to meet with the study clinician on 11 occasions: two (2) visits for informed consent and baseline assessment, one (1) visit prior to FMT for colonoscopy instructions and exam, one (1) visit for the fecal microbiota transplant procedure by colonoscopy at an outpatient surgical center, seven (7) visits for post-FMT assessment. There are also daily phone calls in the week following the FMT, and weekly phone call visits (during weeks in which there is not a physical visit) to check up on how the subject is doing, any change in medications, side effects, and answer any questions.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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PD patients

This is an open-label clinical trial to evaluate the Safety of fecal microbiota transplant following a 10 day treatment with Vancomycin in adult subjects with Parkinson's disease.

Group Type OTHER

Fecal Microbiota Transplant

Intervention Type COMBINATION_PRODUCT

Fecal Microbiota Transplant

Interventions

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Fecal Microbiota Transplant

Fecal Microbiota Transplant

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Vancomycin

Eligibility Criteria

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Inclusion Criteria

* Individuals diagnosed with PD

Exclusion Criteria

* Non-PD individuals
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ProgenaBiome

OTHER

Sponsor Role lead

Responsible Party

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Sabine Hazan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sabine Hazan

Ventura, California, United States

Site Status

Countries

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United States

Central Contacts

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Alex Lopez

Role: CONTACT

8053390549

Other Identifiers

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PRG-056

Identifier Type: -

Identifier Source: org_study_id

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